Quarterly IRB Newsletters
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Change in IRB Process for Informed Consent Documents - No Site Name and Site Address Required - Effective October 1, 2015 IntegReview no longer requires the study site names/addresses to be included in the informed consent document (ICD). There is no federal regulatory or AAHRPP requirement that requires the inclusion of study site names/addresses to be included in the ICD.
This IRB process change will streamline the processes involved with ICDs and will assist in our obligation to provide you with a more expedient turn-around of your documents. The ICD will continue to include the name of the Principle Investigator and the site contact number(s).
"DRAFT" FDA Guidance - Use of Electronic Consent in Clinical Investigations - This draft guidance document, distributed in March 2015, provides recommendations for clinical investigators, sponsors, and IRBs on the use of electronic media and processes to obtain informed consent. FDA's requirements for electronic records/ signatures, informed consent, and IRBs are set forth in 21 CFR parts 11, 50, and 56, respectively. The information presented to the subject, processes used for obtaining informed consent, and documentation of the electronic informed consent (eIC) must meet the requirements of these and other applicable regulations. [READ MORE]
May 28, 2019: IntegReview IRB is Pleased to Announce the Latest FDA Routine Audit Finds No Deficiencies
In the past 20 years, IntegReview IRB has experienced four (4) routine inspections from The U.S. Food and Drug Administration (FDA) of their policies and procedures relating to the protection of human subjects in research. The fourth inspection recently occurred on May 20-22, 2019.
“We are pleased to announce that the most recent FDA audit has resulted in no findings or concerns; no deficiencies were observed, and no issuance of a FDA Form 483. We are so very appreciative of our IRB Staff and IRB Members that contributed to the success of this inspection. IntegReview IRB will continue to dedicate the highest ethics and attention to detail to the oversight of research and to the protection of subjects,” said Melissa Meyer, CCRP, President.
“IntegReview IRB is proud of the successful outcome of the inspection and we applaud the performance of our Compliance team and all of our staff who collectively contribute to our Quality Management Program,” said Melanie Flores, CIP, CCRP, Vice President of Compliance.
IntegReview IRB is an AAHRPP-accredited independent IRB based in Austin, Texas. It is a certified woman-owned business and is celebrating its 20th anniversary. IntegReview provides exemplary quality-driven ethical review (IRB services) for pharma, medical device, biotech and researchers across the U.S., Latin America and Japan.
July 11, 2018: IntegReview IRB Adds Renowned Professor Emeritus to Team
IntegReview IRB announces that Ernest D. Prentice, Ph.D. has joined the organization as a Senior Consultant to the IRB. In his new role, Dr. Prentice will work with IntegReview leadership to provide consultation to the IRB and educate researchers by speaking at upcoming research conferences. “We are thrilled to work with someone as experienced and knowledgeable as Dr. Prentice,” said Melissa Meyer, CCRP, President of IntegReview IRB. “He has an incredible, respected reputation from his work at the Department of Genetics, Cell Biology and Anatomy at the University of Nebraska Medical Center [Professor Emeritus]. With his background and involvement with Institutional based and Central IRBs, we are honored for him to join the IntegReview team.”
May 16, 2017: IntegReview IRB and Veritas IRB announce partnership to provide accredited ethics review services in the U.S. and Canada
IntegReview IRB partnered with Canadian-based Veritas IRB Inc., to provide ethics review services and risk management consulting to sponsors of research and investigators in both the United States and Canada. Through their combined efforts, IntegReview IRB and Veritas IRB will ensure a seamless and comprehensive review in full compliance with regulatory and ethical requirements in both countries. The partnership allows IntegReview IRB to have a strategic geographic presence in order to provide to its clients with seamless high quality services and human research protections oversight for research participants in the United States and Canada.
2020 Upcoming Events
|DATE||CONFERENCE / EVENT||LOCATION||ASSOCIATION|
|May 1 - 4||ACRP||(Virtual Conference)|
|June 15-17||DIA||(Virtual Conference)||Exhibit|
Future conferences (exhibitor and attendence) will be updated shortly as travel restrictions are updated. #Staywell